{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63309",
      "recalling_firm": "Abbott Point Of Care Inc.",
      "address_1": "400 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.",
      "recall_number": "Z-0192-2013",
      "product_description": "Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039)    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039)    Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.",
      "product_quantity": "154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.)  1 box contains six, 3ml plastic bottles.",
      "reason_for_recall": "Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.",
      "recall_initiation_date": "20120719",
      "center_classification_date": "20121102",
      "termination_date": "20130620",
      "report_date": "20121114",
      "code_info": "Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039)    Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039)    Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)"
    }
  ]
}